Aclaris Therapeutics, Inc. 12th Annual Cantor Fitzgerald Global Healthcare Conference

Thank you. Thank you for having us.

Sure. What I'll do maybe is give you an overview of what the next 9 months looks like.

Next up on deck is we're going to be releasing, in tandem on the same day, both bispecific data sets, both 1B's in asthma and atopic dermatitis, and that's with our IL-4Rα TSLP asset. Subsequent to that, the next data set that you'll get is a TSLP mAb in atopic dermatitis. That'll be gapped by about six weeks or so. Intermingled within that, we have some regulatory milestones in that ATI-2138, our oral ITK/JAK3, will start our study in lichen planus in the fourth quarter. Finally, we will be getting into IND with our next gen ATI-9494.

The importance of those two small molecule, I guess, regulatory catalysts is that that actually paints the path for data disclosures in early 2027, in fact, and I think a lot of people don't realize that on the LP study, although we're formally disclosing data top line on ATI-2138 in the second half of 2027, there's an opportunity to pull that forward. We're going to enroll most vigorously in oral mucosal LP, and then we're going to take an interim look at that data when about 60% of the patients are through 16-week endpoint. If that is positive, because we have Fast Track designation, we ought to be able to go have a conversation with the agency about perhaps a registrational study. That could happen as early as the first half. No promises, but that's- Okay that's what we're kind of guiding to.

Finally, you'll get SAD/MAD and POC data on 9494, the next gen ITK, also, throughout 2027.

Yeah, so we actually, as I think you remember, we took a long time to think about down selecting to the right indication, and we decided to go with a niche indication like LP, and it was for a variety of reasons. One is obviously there's nothing approved in that category. I think the second most important is the mechanistic fit. I have yet to have come across such an ideal mechanistic fit with this drug in that we know that LP is driven through an antigenic stimulation of the T cell receptor, and this is exactly what the ITK portion of our molecule does. And we also know that JAK3 in some literature reports is overexpressed in mucosal LP lesions. So in both ways, both upstream and downstream, we're impacting the disease from a mechanistic standpoint.

The other thing I really like about this indication is that the pathophysiology is the same, but it generates three distinct phenotypes.

One is mucosal, which typically affects patients in the oral cavity area, also in the genital area in females. Then cutaneous, and the way to think about that is just like moderate to severe AD. Then third is just the scalp involvement, which is called lichen planopilaris, and that you can get fibrosis, scarring, and eventual hair loss. So, you basically get a three for one, I guess is the best way to say it. We've designed a basket study that encompasses all three phenotypes. We'll have about 40 some odd patients per dose group. We're going to look at 10 and 20 milligrams BID plus placebo. Again, the first to enroll will be mucosal.